FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on December 23, 2021 - 00:45 GMT

FDA In Brief: FDA Announces Outbreak Investigation of Listeria monocytogenes Found in Dole Packaged Salad

For Immediate Release: December 22, 2021 The following quote is attributed to Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response: “The FDA, along with the CDC and our state and local partners, is investigating a multistate outbreak of …

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Published on December 22, 2021 - 18:02 GMT

Coronavirus (COVID-19) Update: FDA Authorizes First Oral Antiviral for Treatment of COVID-19

For Immediate Release: December 22, 2021 Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to- …

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Published on December 21, 2021 - 22:46 GMT

Coronavirus (COVID-19) Update: December 21, 2021

For Immediate Release: December 21, 2021 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: On December 20, the FDA’s Center for Veterinary Medicine (CVM) announced an …

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Published on December 21, 2021 - 21:56 GMT

FDA In Brief: FDA Announces Outbreak Investigation of Listeria monocytogenes Found in Fresh Express Packaged Salad

For Immediate Release: December 21, 2021 The following quote is attributed to Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response “The FDA, along with the CDC and our state and local partners, is working to investigate a multistate outbreak …

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Published on December 21, 2021 - 19:20 GMT

FDA Conditionally Approves First Oral Tablet to Treat Chemotherapy-Induced Diarrhea in Dogs

For Immediate Release: December 21, 2021 Today, the U.S. Food and Drug Administration conditionally approved Canalevia-CA1 (crofelemer delayed-release tablets) for the treatment of chemotherapy-induced diarrhea in dogs. This is the first treatment to be …

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Published on December 21, 2021 - 16:58 GMT

FDA Grants Marketing Authorization for Inferior Vena Cava Filter Removal Device

For Immediate Release: December 21, 2021 Today, the U.S. Food and Drug Administration authorized marketing of the first laser-based device for the removal of Inferior Vena Cava (IVC) filters. The device is designed for patients who have an IVC filter, a …

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Published on December 20, 2021 - 20:53 GMT

FDA Approves First Injectable Treatment for HIV Pre-Exposure Prevention

FDA News Release Drug Given Every Two Months Rather Than Daily Pill is Important Tool in Effort to End the HIV Epidemic For Immediate Release: December 20, 2021 Today, the U.S. Food and Drug Administration approved Apretude (cabotegravir extended-release …

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Published on December 17, 2021 - 22:09 GMT

FDA Approves New Treatment for Myasthenia Gravis

FDA News Release Approval is the First of a New Class of Medication for this Rare, Chronic, Autoimmune, Neuromuscular Disease For Immediate Release: December 17, 2021 The U.S. Food and Drug Administration today approved Vyvgart (efgartigimod) for the …

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Published on December 17, 2021 - 21:18 GMT

Coronavirus (COVID-19) Update: December 17, 2021

For Immediate Release: December 17, 2021 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: On December 15, 2021, the FDA approved an abbreviated new drug application ( …

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Published on December 15, 2021 - 17:19 GMT

FDA Approves First Drug to Prevent Graft Versus Host Disease

For Immediate Release: December 15, 2021 Today, the U.S. Food and Drug Administration approved Orencia (abatacept) for the prophylaxis (prevention) of acute graft versus host disease (aGVHD), a condition that occurs when donor bone marrow or stem cells …

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Published on December 14, 2021 - 21:53 GMT

Coronavirus (COVID-19) Update: December 14, 2021

For Immediate Release: December 14, 2021 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: Today, the FDA is announcing revisions to the Janssen COVID-19 Vaccine Fact …

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Published on November 30, 2021 - 15:13 GMT

Coronavirus (COVID-19) Update: FDA Actively Working to Investigate, Address Potential Impacts of Omicron Variant; Urges ...

For Immediate Release: November 30, 2021 Statement From: Janet Woodcock, M.D. Acting Commissioner of Food and Drugs - Food and Drug Administration As we have with previous emerging COVID-19 variants, the U.S. Food and Drug Administration is actively …

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Published on November 29, 2021 - 15:52 GMT

FDA Approves New Imaging Drug to Help Identify Ovarian Cancer Lesions

For Immediate Release: November 29, 2021 The U.S. Food and Drug Administration today approved Cytalux (pafolacianine), an imaging drug intended to assist surgeons in identifying ovarian cancer lesions. The drug is designed to improve the ability to locate …

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Published on November 23, 2021 - 22:14 GMT

FDA Approves First Treatment for Common Type of Post-Transplant Infection that is Resistant to Other Drugs

FDA News Release Approval is for Cytomegalovirus, a Type of Herpes Virus For Immediate Release: November 23, 2021 Today, the U.S. Food and Drug Administration approved Livtencity (maribavir) as the first drug for treating adults and pediatric patients (12 …

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Published on November 23, 2021 - 20:29 GMT

Coronavirus (COVID-19) Update: November 23, 2021

For Immediate Release: November 23, 2021 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: Related Information ### Boilerplate The FDA, an agency within the U.S. …

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Published on November 19, 2021 - 18:15 GMT

FDA Approves First Drug to Improve Growth in Children with Most Common Form of Dwarfism

For Immediate Release: November 19, 2021 Today, the U.S. Food and Drug Administration approved Voxzogo (vosoritide) injection to improve growth in children five years of age and older with achondroplasia and open epiphyses (growth plates), meaning these …

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Published on November 19, 2021 - 15:13 GMT

FDA In Brief: FDA Issues Final Orders Reclassifying Certain Hepatitis C Diagnostic Tests from Class III to Class II

For Immediate Release: November 19, 2021 The following quote is attributed to Timothy Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in FDA’s Center for Devices and Radiological Health: “Today’s action allows …

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Published on November 19, 2021 - 13:48 GMT

Coronavirus (COVID-19) Update: FDA Expands Eligibility for COVID-19 Vaccine Boosters

For Immediate Release: November 19, 2021 Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUA) for both the Moderna and Pfizer-BioNTech COVID-19 vaccines authorizing use of a single booster dose for all individuals 18 …

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Published on November 16, 2021 - 21:29 GMT

FDA In Brief: FDA Announces Investigation of E. coli O157:H7 Outbreak Linked to Spinach

For Immediate Release: November 16, 2021 The following quote is attributed to Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response: “The FDA, along with the CDC and our state and local partners, is working to investigate a multistate …

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Published on November 16, 2021 - 19:57 GMT

Coronavirus (COVID-19) Update: November 16, 2021

For Immediate Release: November 16, 2021 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: Related Information ### Boilerplate The FDA, an agency within the U.S. …

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